Study on usefulness of sitagliptin in patients with type 2 diabetes

Study on usefulness of sitagliptin in patients with type 2 diabetes - JUMP study (Januvia on renal biomarkers and blood pressure)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007477

Enrollment

200

Registered

2012-03-09

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 2 diabetes (nephropathy stage I-III)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who fulfill the following criteria will be included in the study: 1) Patients who had received diet / exercise therapy alone or diet / exercise therapy and antidiabetic agents for more than 4 weeks, and whose blood glucose has not been sufficiently controlled (HbA1c 6.5% or fasting blood glucose 130mg/dL or casual blood glucose 180mg/dL). 2) Patients with diabetic nephropathy at stage I (pre-nephropathy) to stage III (overt proteinuria). 3) Patients for whom change of concomitant drugs including antihypertensives is considered not necessary in principle for at least 6 months 4) Outpatients aged20 years of both sexes who have given written informed consent on use of their data

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. 1) Patients with type 1 diabetes 2) Patients before or after operation, and those with severe infections or serious injury 3) Pregnant, possible pregnant, or lactating women 4) Patients with severe kidney dysfunction (serum creatinine2.5 mg/dL) 5) Patients with a history of hypersensitivity to Januvia 6) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Design outcomes

Primary

Measure	Time frame
Change and %change in HbA1c after 12 months from baseline	—

Secondary

Measure	Time frame
Changes and %changes in the following parameters during the observation period Office blood pressure Home blood pressure (In principle, 7 values collected at each visit should be used for evaluation). Body weight Urinary albumin/creatinine eGFR Novel biomarkers including urinary megalin Exploratory analyses At the completion of the treatment period, stratified analyses based on background variables (status of monotherapy / combination therapy, age, and diabetic nephropathy stage, etc) will be conducted to evaluate the usefulness of Januvia in reducing blood glucose. Moreover, its association with HbA1c, blood pressure, albuminuria, eGFR, and novel biomarkers will be analyzed.	—

Measure

Time frame

Changes and %changes in the following parameters during the observation period Office blood pressure Home blood pressure (In principle, 7 values collected at each visit should be used for evaluation). Body weight Urinary albumin/creatinine eGFR Novel biomarkers including urinary megalin Exploratory analyses At the completion of the treatment period, stratified analyses based on background variables (status of monotherapy / combination therapy, age, and diabetic nephropathy stage, etc) will be conducted to evaluate the usefulness of Januvia in reducing blood glucose. Moreover, its association with HbA1c, blood pressure, albuminuria, eGFR, and novel biomarkers will be analyzed.

—

Countries

Japan

Contacts

Public ContactAkihiko Saito

Niigata University Graduate School of Medical and Dental Sciences Department of Applied Molecular Medicine

akisaito@med.niigata-u.ac.jp025-227-0915

Outcome results